Prostate extract supplemented with zinc

ABSTRACT

A composition of matter comprising crystalline zinc chelated with animal prostate extract provides a convenient source of both fatty acids and zinc for dietary and therapeutic purposes. The pharmaceutical composition is useful for the treatment of diabetes.

UNITED STATES GOVERNMENT INTEREST IN THE INVENTION

This invention was made with United States Government support; namely,the facilities, equipment, and materials of the Department of VeteransAffairs. The U.S. Government has certain rights in this invention in theUnited States.

RELATED APPLICATION

This application is a 371 of PCT/US94/02909 and is acontinuation-in-part of U.S. application Ser. No. 08/179,761, filed Jan.7, 1994, now issued as U.S. Pat. No. 5,411,748, which is a continuationof application Ser. No. 07/964,879, filed Oct. 22, 1992, now abandoned.

FIELD OF THE INVENTION

The present invention relates to compositions and pharmaceuticalpreparations that contain zinc prostate extract supplemented with zinc

BACKGROUND OF THE INVENTION

Diabetes is one of the most common metabolic disorders in humans.Indeed, nearly 1 million Americans are afflicted with juvenile-onsetdiabetes. This form of the disease is also known as insulin-dependent orType I diabetes, and usually appears abruptly during childhood or youngadulthood. Type II, or non-insulin-dependent diabetes is characterizedby a less abrupt onset. Type II diabetes commonly occurs beyond the ageof 40 or so. Both types of diabetes impair the body's ability to accessblood glucose for use as an energy source. Chronically high levels ofblood sugar gradually damage many tissues and organs of the body.

Substantial efforts have been directed toward understanding the causesand consequences of diabetes. A strong autoimmune component is nowbelieved important in the etiology of type I diabetes (see Science225:1381 (1984), and Immunology Today 5:230 (1984)). The metabolicconsequences of experimentally induced diabetes have also been explored.For example, in Diabetes 31:426 (1982) Schneir et al. demonstrated thatcollagen, an important structural protein of skin, has a significantlydecreased half-life in diabetic rats. It is well appreciated that bothforms of diabetes impact the tissues of the body in a global fashion.

Despite the availability of insulin treatment, diabetes remains aserious disease that is responsible for many deaths and substantialmorbidity worldwide. For example, the life-span of the average diabeticis shortened by as much as 50%. Although insulin treatment can assist inregulating blood sugar levels, the degree of this control is typicallyinsufficient to prevent many of the sequelae from diabetes. Theconsequences from long term diabetes can include eye damage, oftenleading to blindness; circulatory problems; problems with wound healing;and other serious consequences. Improved treatments for diabetes areurgently required.

SUMMARY OF THE INVENTION

One aspect of the present invention is a composition of mattercomprising a crystalline zinc chelated with extract of animal prostatetissue.

Another aspect of the present invention is a pharmaceutical compositionthat can be administered to a mammal. This pharmaceutical compositioncomprises crystalline zinc chelated with extract of animal prostatetissue and at least one pharmaceutically acceptable excipient. Thecomposition can take the form of either a tablet or capsule. Each tabletor capsule of this composition preferably contains from about 20 to 150milligrams of zinc.

A further aspect of the present invention is a method of treatingdiabetes. According to this method, a pharmaceutical composition thatcomprises a zinc chelated prostate extract is administered to a diabeticmammal in a quantity sufficient to reduce blood glucose concentration inthat mammal.

Yet a further aspect of the present invention regards a pharmaceuticalcomposition comprising an extract of animal prostate tissue for use inthe treatment of diabetes. In a preferred embodiment, the pharmaceuticalcomposition also comprises zinc.

Another aspect of the present invention is the use of an organic extractof animal prostate tissue in the preparation of a medicament for thetreatment of diabetes.

Another aspect of the present invention is the use of prostate extractfor the treatment of diabetes. The extract is preferably supplementedwith zinc. Prostate extract can also be used in the preparation of amedicament for the treatment of diabetes. In one embodiment, theprostate tissue comprises a first group of molecules that are soluble inpetroleum either or hexane. A subset of the molecules that are solublein petroleum either or hexane is present in the prostate tissue. Theprostate tissue also comprises a second group of molecules that aresoluble in ethyl acetate or chloroform. The extract of animal prostatetissue can be obtained by a process comprising first mincing the tissue,and resuspending the minced tissue in an aqueous solution. A first groupof molecules can then be extracted from the resuspended tissue using afirst, nonpolar solvent that is less polar than petroleum either andhexane. The first solvent containing the first group of molecules canthen be discarded. The second group of molecules can then be extractedusing a second solvent that is more polar than the first solvent.Finally, the desired prostate extract can be created by removing thesecond solvent.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 shows the zinc concentrations of organ tissues of normal ratswith and without prostate extract treatment. The open bars indicatewithout prostate extract and the cross-hatched bars indicates withprostate extract. In this figure, * indicates P<0.05 and ** indicatesP<0.001.

FIG. 2 shows zinc concentrations of organ tissues of diabetic rats withand without prostate extract treatment. The open bars indicate withoutprostate extract and the cross-hatched bars indicates with prostateextract. In this figure, * indicates P<0.05 and ** indicates P<0.001.

FIG. 3 shows a comparison of zinc concentrations in organ tissues ofnormal and diabetic rats with and without prostate extract. NC refers tonormal rats without prostate extract treatment. NP refers to normal ratswith prostate extract treatment. DC refers to diabetic rats withoutprotate extract treatment. DP refers to diabetic rats with prostateextract treatment. In this figure, ** indicates P<0.001 when the valuesof protate extract treated rats are compared with those of untreatedrates, and ## indicates P<0.001 when the values of diabetic rats arecompared with those of normal rats.

DETAILED DESCRIPTION OF THE INVENTION

Introduction

I have discovered that a composition of matter comprising a zincchelated with extract of animal prostate tissue is useful for thetreatment of diabetes. This composition may also be useful in treatingother conditions that affect zinc and essential fatty acid metabolism.

For at least 60 years, the biomedical community has appreciated the factthat zinc metabolism is altered as a consequence of the diabeticcondition. For example, in J. Clin. Invest. 17:725 (1938), Scott et al.showed that zinc is essential for insulin storage in the pancreaticB-cells of humans. In Virchows Arch. B4:94-302 (1970), Engelbart andKief showed that acute stimulation of insulin secretion in rats reducedthe zinc content in the B-cells of their pancreata. It is also wellknown that zinc participates in the storage of insulin, and that theamount of insulin stored during zinc deficiency is less than when zinclevels are normal. Thus, the important relationship between zincmetabolism and diabetes has been clearly established in the scientificliterature.

An experimental finding presented under Example 1 confirmed thatenhanced survival of diabetic test animals correlated with increasedlevels of dietary zinc. Based on this observation, I hypothesized that adietary supplement which facilitated zinc utilization would also providebenefits to diabetic patients.

I considered prostaglandin precursors as possible diabetes therapeuticagents that could improve the symptoms associated with diabetes. Myinvestigations concentrated on these substances because Song and Adhamhad previously demonstrated that at least some prostaglandins (PGE₂) canact as zinc-binding ligands (J. Nutrition 109:2152 (1979)). The authorsof this report also showed that other prostaglandins (PGA₂ and PGB₂) hadno influence on zinc transport. Thus, only a subset of prostaglandinseffectively chelated zinc, or otherwise influenced zinc transport.Additionally, in Life Sciences 42:687 (1988), Song and Mooradianspeculated that arachidonic acid, a prostaglandin precursor, played arole in the control of zinc flux across the intestinal epithelium ofdiabetic rats. Arachidonic acid is another example of a prostaglandinprecursor.

Although it would seem desirable to alleviate diabetic symptoms bydirectly administering an appropriate prostagiandin, this approach isimpractical. The fact that prostaglandins have very short half-livesprohibits their use as therapeutics.

Since prostaglandins are synthesized from unsaturated fatty acidprecursors, I focused on these latter compounds as candidates fordiabetes therapeutics. Furthermore, my search concentrated on sources ofunsaturated fatty acids that could be administered as dietarysupplements. Altogether, three different sources of unsaturated fattyacids were tested as diabetes therapies.

The results from side-by-side comparisons of arachidonic acid, eveningprimrose oil, and a novel extract of animal prostate tissue indicatedmarked differences between the effectiveness of these agents as diabetestherapeutics. Specifically, the extract of animal prostate tissue mosteffectively lowered blood glucose, and raised cytosolic tissue glucoseconcentrations in experimental rats.

Most significantly, my investigations demonstrated that encapsulatedzinc chelated prostate extract lowered the blood glucose readings ofdiabetic humans. This finding confirmed the effectiveness of this novelcomposition as a viable diabetes therapy.

I. Crystalline Zinc Chelated with Prostate Extract

One aspect of the present invention is zinc chelated with prostateextract; i.e., crystals in which negatively charged fatty acids that arepresent in an organic extract of prostate tissue are bound by positivelycharged zinc ions.

Preferably, the organic extract of prostatic tissue contains unsaturatedfatty acids that comprise essential fatty acids. The essential fattyacids preferably are selected from the group consisting ofprostaglandins and prostaglandin precursors. These fatty acids can beobtained from the prostates of animals such as the cow, sheep, or goat.The extraction can be accomplished by resuspending the prostates in abuffered aqueous solution, extracting the saturated fatty acids with ahighly nonpolar organic solvent such as petroleum ether or hexane,extracting unsaturated fatty acids with a more polar organic solventsuch as ethyl acetate or chloroform, and then adding a zinc salt in aquantity sufficient to chelate the fatty acids or amino acids present.

II. Pharmaceutical Compositions

Further aspects of the present invention regard pharmaceuticalcompositions. Pharmaceutical compositions, according to the presentinvention, contain: (1) an extract of animal prostate tissue, (2) a zincsalt such as zinc sulfate, (3) a protein hydrolysate, and (4) at leastone pharmaceutically acceptable excipient.

The protein hydrolysate may be in the form of amino acids orincompletely hydrolyzed proteins such as proteoses, peptones, or otherpartially hydrolyzed proteins, such as albumin.

The pharmaceutical compositions prepared according to the presentinvention preferably contain essential fatty acids, zinc sulfate, andprotein hydrolysate in a ratio of about 10:1:5 by weight. Thepharmaceutical compositions can be packaged in tablet or capsule form byprocedures that are well known in the pharmaceutical arts. Preferably,each tablet or capsule contains about 200 mg of prostate extract, about20 mg of zinc and about 100 mg of protein hydrolysate, in addition tothe pharmaceutically acceptable excipient or excipients. Suitableexcipients for tablets and capsules include inert diluents, such ascalcium carbonate, sodium carbonate or bicarbonate, lactose, or calciumphosphate; or binding agents, such as starch, gelatin, or acacia; orlubricating agents, such as magnesium stearate, stearic acid, or talc.The coating of the capsules can be gelatin or a soluble polymer, as iswell understood in the art. The tablets or capsules are suitable fororal administration.

The pharmaceutical compositions described herein are useful for thetreatment of diabetes, hypertension, impotence, and other diseases inwhich zinc or prostaglandin metabolism is impaired. In particular,diabetes can be treated by administering the zinc chelated prostateextract of the present invention to a diabetic mammal in a quantitysufficient to reduce blood glucose concentration in the mammal. Typicaldoses for patients with diabetes or hypertension, stated as the quantityof zinc, are from about 80 mg to about 150 mg of zinc. These doses canbe adjusted by one of ordinary skill in the art according to suchfactors as the weight, age, sex, and state of health of the patient, aswell as according to the response to a particular dosage.

In the experiments illustrated in FIGS. 1 and 2, rats were anesthetizedand then given 200 mg of prostate extract plus 200 μg zinc in 2 mldistilled water by intragastric intubation two hours before sacrifice.All the values are means ±SEM of six determinations. It can be seen thatthe prostate extract composition had a dramatic effect on zincconcentrations in all tissues tested in normal rats and on blood, heart,lung and pancreas of diabetic rats.

FIG. 3 shows a comparison of zinc concentrations in organ tissues ofnormal and diabetic rats with and without prostate extract from the datashown in FIGS. 1 and 2. The mean values of tissue zinc concentrations innormal and diabetic rats treated with and without prostate extract werecompared. It can be seen that there is a significant difference betweennormal and diabetic rats and also that prostate extract had asignificant effect on both normal and diabetic rats.

The experiment described below in Example 1 illustrates a fundamentalrelationship between the level of dietary zinc consumption and longevityin diabetic rats. In this procedure, laboratory rats were made diabeticby injection with a chemical agent that is well known in the art. Thediabetic rats were then fed diets that provided zinc in amounts thatranged from inadequate to excessive. The results from this simpleexperiment confirmed that dietary zinc influenced the life span ofdiabetic test animals.

EXAMPLE 1 Effect of Dietary Zinc on the Survival of Diabetic Rats

Fifty-one rats were divided into three groups of 17 rats each. All ofthe rats were made diabetic by injection of streptozotocin (50 mg/kg).One week later the three groups of rats were fed diets having definedquantities of zinc. The first group was fed a zinc-deficient diet (1 μgZn/g), the second group was fed a zinc-adequate diet (37.5 μg Zn/g), andthe third group was fed a diet containing excess zinc (1 mg Zn/g). Thenumber of surviving rats was counted after 25 days. The resultspresented in Table 1 summarize the survival of the test animals in thisexperiment.

                  TABLE 1                                                         ______________________________________                                        THE SURVIVAL RATE OF DIABETIC RATS FED WITH                                   DIFFERENT CONCENTRATIONS OF ZINC                                              SURVIVAL RATES (No of Survived rats/No of diabetic rats)                      (l μg Zn/g)                                                                              (37.5 μg Zn/g)                                                                        (1 mg Zn/g)                                          Zinc-Deficient                                                                                  Zinc-Adequate                                                                              Zinc-Excess                                    ______________________________________                                        8/17          11/17      15/17                                                ______________________________________                                    

Example 2 describes the procedure that was used to isolate unsaturatedfatty acids from animal prostate tissue. Prostate tissue contains zinc,prostaglandins, essential fatty acids, citric acid, testosterone andproteins. However, there is no evidence to indicate that an organicextract of prostate tissue is limited to these substances.

EXAMPLE 2 Preparation of Crystalline Zinc Chelated Prostate Extract

Bovine prostates were obtained from a slaughterhouse, minced into smallpieces and frozen at -70° C. The sliced tissue was suspended in a10-fold excess (w/v) of 6.0 mM Tris-HCl buffer, pH 8.0, disrupted with aVIRTIS-45 homogenizer (Virtis Co., Gardner, N.Y.), and centrifuged at 4°C. for 20 minutes at 3,000×g. The upper part of the fat was removedphysically, and the supernatant was incubated at 37° C. for one hour.The saturated fatty acids were extracted with petroleum ether. Theremaining aqueous solution, which included unsaturated fatty acids, wasacidified to pH 3.0 with 0.2 N HCl, and the unsaturated fatty acidmixture including prostaglandins was extracted 2 to 3 times with onevolume each time of ethyl acetate mixed with isopropanol (1:1 v/v) orchloroform. The ethyl acetate or chloroform extracts were then combined.The unsaturated fatty acid solutions were either freeze-dried orevaporated to dryness under vacuum. The oil-like prostate extract thatresulted from these procedures included unsaturated fatty acids. Apreparation of zinc chelated unsaturated fatty acids was formed bymixing 200 mg of prostate extract with 20 mg zinc chloride and 100 mg ofprotein hydrolysate that was purchased from Sigma (St. Louis, Mo.).

Example 3 describes a procedure that was used to assess the effects ofarachidonic acid, evening primrose oil and prostate extract on thesymptoms of diabetic rats. Three sources of unsaturated fatty acids weretested for their relative abilities to improve the symptoms of diabeticrats. Arachidonic acid and evening primrose oil were two of thesubstances used in making this comparison. Evening primrose oil is knownto be a rich source of both linoleic acid and linolenic acid. I alsoprepared and tested an organic extract of animal tissue as a source ofunsaturated fatty acids that could positively influence diabeticsymptoms in rats. All of the substances were administered as dietarysupplements in conjunction with a dissolved zinc salt. My findingsindicated the prostate extract most advantageously influenced thesymptoms of diabetic rats.

EXAMPLE 3

Investigation of the Effects of Unsaturated Fatty Acids on the Symptomsof Diabetic Rats

Rats were first made diabetic by injection with streptozotocin. Thesediabetic rats Were then administered one of three unsaturated fatty acidpreparations in their drinking water. The drinking water containeddissolved zinc sulfate together with either arachidonic acid, eveningprimrose oil or prostate extract that was prepared in accordance withthe method of Example 2. The zinc sulfate solution was diluted toprovide a final concentration of 10 mg/l of zinc. The arachidonic acidand prostate extract were each diluted to final concentrations of 100mg/l. The evening primrose oil was diluted to a final concentration of500 mg/l. The zinc and prostate extract concentrations used in thisprocedure were chosen to proportionally approximate a dosage that wouldbe given to an adult human. In calculating the concentrations, I assumedthat a 60 kg diabetic human would consume a daily dosage of 600-1000 mgof prostate extract and 60-100 mg zinc. This amounted to 10 mg ofprostate extract and 1 mg of zinc per kg of body mass. The estimateddaily water consumption for a normal rat was 40 ml. At 18 dayspost-streptozotocin injection, blood glucose measurements were recordedfor all test animals using a GLUCOMETER ELITE (Miles Co.). The resultsof these glucose measurements are presented in Table 2.

                  TABLE 2                                                         ______________________________________                                        BLOOD GLUCOSE CONCENTRATION (in mg/100 ml) IN                                 DIABETIC RATS CHANGES AFTER CONSUMING WATER                                   CONTAINING DIFFERENT CONSTITUENTS                                             Experimental                                                                  Conditions                                                                                  Initial Values                                                                           Final Values                                                                            Improved Values                            ______________________________________                                        Normal Rats                                                                            83.6 ± 2.6                                                        D-18d-Zn-PE                                                                                495.0 ± 24.7                                                                         341.4 ± 17.4                                                                          153.6 ± 10.5                             D-18d-Zn-AA                                                                                435.6 ± 24.7                                                                         353.4 ± 10.9                                                                          91.6 ± 24.4*                             D-18d-Zn-EPO                                                                              355                              -63                              D-18d-Zn only                                                                            374.2 ± 37.6                                                                           377.0 ± 43.3                                                                           0.8 ± 24.3**                            D-18d-DW        321                          -48                              ______________________________________                                         *P < 0.05 compared to the values of D18d-Zn-PE                                **P < 0.05 compared to the values of D18d-Zn-PE                               D18d = 18 days after induction of diabetes                                    ZnPE = Drinking water contained 10 mg Zn plus 100 mg of prostate              extract/liter                                                                 ZnAA = Drinking water contained 10 mg Zn plus 100 mg of arachidonic           acid/liter                                                                    D18d-EPO = Drinking water contained 8 mg Zn plus 500 mg of Evening            Primrose oil/liter                                                            Znonly = Drinking water contained 10 mg Zn/liter                              DW = Distilled water                                                     

The results shown in Table 2 confirmed that diabetic animals hadsignificantly higher blood glucose levels than normal rats.Administration of zinc alone to diabetic rats did not effect bloodglucose levels. Dietary administration of zinc together with eveningprimrose oil was also ineffective in reducing the blood glucoseconcentration of the diabetic animals. The combination treatment of zincand arachidonic acid moderately reduced blood glucose concentrations.Surprisingly, the reduction of blood glucose that followedadministration of zinc and prostate extract was clearly more pronouncedthan for any other treatment.

That prostate extract should efficiently reduce the blood glucoseconcentration of diabetic animals while evening primrose oil andarachidonic acid were ineffective or moderately effective, was anunexpected result. Significantly, this finding demonstrated that allsources of unsaturated fatty acids are not equal in their capacities toimprove diabetic symptoms.

To independently assess a second indicator of the diabetic condition,cytosolic glucose concentrations were determined for various tissues indiabetic rats that had undergone various dietary supplementations.Example 4 presents the results of such determinations that were madeusing rats treated exactly as described under Example 3.

EXAMPLE 4 Cytosolic Glucose Concentrations in Various Tissues ofDiabetic Rats

Immediately following sacrifice of the experimental animals from Example3 by injection of nembutal (50 mg/kg), various tissues were isolated andstored at -70° C. Each tissue was disrupted in a polytron homogenizerand then centrifuged at 2,000×g for 20 minutes. The supernatants wereeither stored frozen or immediately used for determining glucose andprotein concentrations. Glucose concentrations were measured using amodel A23 glucose analyzer that was purchased from Yellow SpringsInstruments Co. (Yellow Springs, Ohio). Protein concentrations weredetermined according to the method described by Lowry et al. in J. Biol.Chem. 193:265 (1951). The values obtained for the glucose readings weredivided by the protein concentration readings to normalize themeasurements. This normalization was necessary to control for thevariable masses and protein yields that distinguished batches ofdifferent tissues. The results are shown in Table 3.

                                      TABLE 3                                     __________________________________________________________________________    GLUCOSE CONCENTRATIONS OF DIFFERENT ORGAN CELL                                CYTOSOLS OF DIABETIC RATS FED DIFFERENT DIETS                                 Glucose Concentration (mg glucose/mg protein)                                 Organs                                                                             Zinc plus PE                                                                         Zinc plus AA                                                                          Zinc Only                                                                             Zinc plus EPO                                                                        Dist. Water                                __________________________________________________________________________    Heart                                                                              184.3 ± 19.6                                                                      151.8 ± 14.0                                                                       111.9 ± 15.8*                                                                      86.4   97.0                                       Lung        64.3 ± 9.5                                                                    59.3 ± 6.3                                                                          57.9 ± 10.3                                                                         56.8                                                                                      51.0                             Liver                                                                                    181.8 ± 26.4                                                                149.7 ± 22.O*                                                                       122.1 ± 17.5*                                                                        123.1                                                                                      124.4                             Pancreas                                                                              152.8 ± 11.1                                                                   126.0 ± 6.4#                                                                          128.4 ± 12.2#                                                                        89.6                                                                                      112.2                            Spleen                                                                                  131.0 ± 3.6                                                                   103.1 ± 7.4**                                                                        123.2 ± 9.1                                                                          123.1                                                                                    124.4                             Kidney                                                                                  200.8 ± 15.4                                                                 157.5 ± 12.7#                                                                        150.8 ± 11.5*                                                                        119.3                                                                                     118.9                             Muscle                                                                                  638.5 ± 67.0                                                                  398.5 ± 41.2**                                                                     383.0 ± 43.7**                                                                       317.7                                                                                      338.5                             Intest.                                                                                970.2 ± 74.0                                                                  685.6 ± 90.1*                                                                      *792.8 ± 94.3#                                                                         605.4                                                                                     702.2                             Total Ave.                                                                           315.5 ± 112.2                                                                    228.9 ± 74.4*                                                                       233.8 ± 86.9*                                                                     190.2 ± 65.6                                                                      208.6 ± 76.7                           __________________________________________________________________________     #Significant at P = 0.05 when compared the values of those rats given         water containing prostate extract (PE) plus zinc.                             *Significant at P < 0.05 when compared the values of those rats given         water containing PE plus zinc.                                                **Significant at P < 0.01 when compared the values of those rats given        water containing PE plus zinc.                                           

The results in Table 3 indicated a correlation between dietarysupplementation with prostate extract and enhanced glucose uptake at thecellular level. Whereas diabetic tissues typically had low levels offree glucose, my results showed this level was dramatically increased intest animals that received the combination of prostate extract and zinc.Dietary administration of either arachidonic acid or evening primroseoil in combination with zinc had no effect on cytosolic glucoseconcentrations. The next step in the development of my invention was toextend the use of zinc chelated prostate extract beyond the treatment oflaboratory animals.

The effectiveness of prostate extract in alleviating the symptoms ofdiabetic humans was also investigated. Example 5 describes changes inblood glucose concentrations that were recorded for diabetic volunteersafter dietary supplementation with capsules that contained zinc chelatedprostate extract.

EXAMPLE 5 Effect of Dietary Administration of Prostate Extract on BloodGlucose levels of Diabetic Humans

Sixteen diabetic individuals were identified and recruited as volunteersto test the effects of dietary supplementation with zinc chelatedprostate extract. Initial blood glucose readings were taken for allindividuals using a GLUCOMETER ELITE (Miles Co.). All 16 volunteers thenconsumed encapsulated zinc chelated prostate extract 2-4 times each dayfor a period of 1 to 3 months. Each capsule contained 200 mg of prostateextract, 20 mg of zinc and gelatin. These capsules were prepared byBanner Pharmacap Co. (Chatsworth, Calif.) using zinc chelated prostateextract prepared according to the method detailed under Example 2. Atthe end of the test period, blood glucose measurements were repeated forall subjects. Table 4 summarizes the results of all blood glucosereadings in this experiment.

                  TABLE 4                                                         ______________________________________                                        BLOOD GLUCOSE CONCENTRATIONS OF MILD DIABETIC                                 PATIENTS AFTER THE INTAKE OF BOVINE PROSTATE                                  EXTRACT SUPPLEMENTED WITH ZINC CAPSULE                                                               Range of Glucose                                                                         Range of Glucose                            Patient                                                                               Patient                                                                               Patient                                                                               Concentration                                                                            Concentration                              Initials                                                                             Age          Sex                                                                                   Before Zinc Intake                                                                   After Zinc Intake                          ______________________________________                                        JSS   56       F       190-190 mg/100 ml                                                                         90-135 mg/100 ml                           KIM     76      F       270-370 mg/100 ml                                                                         95-179 mg/100 ml                          SHK     63      M       180-280 mg/100 ml                                                                         120-180 mg/100 ml                         DHS     61      F       180-280 mg/100 ml                                                                         130-170 mg/100 ml                         HGL     59      M       150-240 mg/100 ml                                                                         100-160 mg/100 ml                         HKK     57      M       180-280 mg/l00 ml                                                                         130-180 mg/100 ml                         SBS     61      M       200-290 mg/100 ml                                                                         130-200 mg/100 ml                         SES     62      M       180-250 mg/100 ml                                                                         130-210 mg/100 ml                         CLC     64      M       150-260 mg/100 ml                                                                         90-160 mg/100 ml                          JJK     49      F       280-320 mg/100 ml                                                                         180-240 mg/100 ml                         BSK     59      M       210-350 mg/100 ml                                                                         150-2l0 mg/100 ml                         JAK     51      M       160-250 mg/100 ml                                                                         100-190 mg/100 ml                         KUK     59      M       180-260 mg/100 ml                                                                         140-210 mg/l00 ml                         ESL     58      F       150-240 mg/100 ml                                                                         110-180 mg/100 ml                         PHL     62      M       180-250 mg/100 ml                                                                         110-l60 mg/l00 ml                         HSC     78      F       210-310 mg/100 ml                                                                         150-210 mg/100 ml                         ______________________________________                                        The Means ± SEM of                                                                        236.56 ± 9.19                                                                           152.43 ± 6.88                                  mid points of each value:                                                      Paired t statistics of the two med-points of each value is P                 ______________________________________                                        < 0.0001.                                                                 

Glucose clearance rates were also measured for diabetic patients beforeand after a regimen of dietary administration with zinc chelatedprostate extract. In this experiment, I measured the rate at which adefined amount of glucose is removed from the blood stream of diabeticindividuals. Whereas non-diabetics typically exhibit rapid glucoseclearance rates, diabetic individuals exhibit lower rates. These lowerrates of glucose clearance result from the diminished insulin activitythat characterizes the diabetic condition. An increased rate of glucoseclearance that followed administration of zinc chelated prostate extractindicates a therapeutic effect.

The advantage of using blood glucose clearance rate as an indicator ofefficacy is that this test is not influenced by temporal changes of dietor exercise whereas blood glucose levels are effected. For this reason,comparison of blood glucose clearance rates before and after a regimenof dietary administration of zinc chelated prostate extract is believedto most accurately measure the positive effects of the therapeuticregimen.

Example 6 details the procedure used to measure the effect of dietaryadministration of zinc chelated prostate extract on the glucoseclearance rates of diabetic volunteers.

EXAMPLE 6 The Effect of Zinc Chelated Prostate Extract on the GlucoseClearance Rates of Diabetic Patients

Four diabetic volunteers were first identified at the Sepulveda V.A.Medical Center. After stabilizing their carbohydrate intakes at a levelof 150-200 grams/day for a period of 3 days, glucose clearance rateswere determined after drinking a 225 ml volume of solution thatcontained 75 grams of glucose. Blood glucose measurements were thentaken at 0, 30, 60, 90, 120, 150 and 180 minutes after consuming theglucose solution. Blood glucose measurements were made using a ONE-TOUCHII GLUCOMETER (Lifescan, Inc., Milpitas, Calif.). The clearance rate wasdetermined as the rate at which the glucose concentration decreasedafter having reached a maximal concentration.

After establishing the initial blood glucose clearance rates, threerandomly selected volunteers consumed 4 capsules of zinc chelatedprostate extract each day for a period of 3 months. The composition ofthe capsules used in this procedure was exactly as described underExample 5. The fourth diabetic volunteer was given a placebo. At the endof the 3 month trial period, blood glucose clearance rates were againdetermined for all volunteers. The quantitative results of thisprocedure are presented in Table 5.

                  TABLE 5                                                         ______________________________________                                        GLUCOSE TOLERANCE TEST                                                        (mg Glucose/100 ml blood samples)                                                                          Final       % of                                 Patients #                                                                           Gel Capsules                                                                              Initial GCR                                                                             GCR  Difference                                                                           Change                               ______________________________________                                        1.     Test Capsules                                                                             11        32   21     190.9                                2.      Test Capsules                                                                              57         75                                                                                18     31.6                               3.      Test Capsules                                                                              48         59                                                                                11     22.9                               4.      Placebo            102                                                                               95   -7     -6.8                               5.      Placebo            21                                                                                 20                                                                                -1     -4.8                               ______________________________________                                    

The results presented in Table 5 indicated the glucose clearance ratesof all diabetic volunteers were substantially improved after a 3 monthperiod of consuming zinc chelated prostate extract. A patient whoreceived a placebo treatment showed no such improvement. Because thepatient that received the placebo was only mildly diabetic, his initialglucose clearance rate was more nearly normal than any of the othervolunteers.

Interestingly, the patient receiving the placebo in this test exhibiteda decreased glucose clearance rate over the period of the experiment.This represents an ordinary trend for such a patient, since the glucoseclearance rate becomes progressively lower as the disease becomesprogressively more severe.

The findings presented here indicated that dietary supplementation withzinc chelated prostate extract improved the symptoms associated withdiabetes. Although the mechanism by which prostate extract leads toimproved symptoms in diabetic animals and man is not clearly understood,the powerful effects of prostate extract on the increased intestinalzinc absorption may be contributory. Regardless of the mechanism, I havedemonstrated that dietary supplementation with prostate extract producessuperior results with regard to improving diabetic symptoms whencompared to regimens that include dietary administration with zinc,either alone or in combination with other examples of unsaturated fattyacids.

The present invention provides compositions that are convenient sourcesof both zinc and essential fatty acids. This composition can be used asa dietary supplement or treatment for diabetes or other conditions.Because the metabolism of zinc and the metabolism of essential fattyacids, including prostaglandin precursors, are interlinked, the use ofsuch compositions is more effective than is the use of either zinc orfatty acids alone in treating diabetes.

I claim:
 1. A pharmaceutical composition, comprising:(a) a zinc chelatedextract of animal prostatic tissue; and (b) at least onepharmaceutically acceptable excipient, said pharmaceutical compositionhaving the form of a tablet or a capsule.
 2. The pharmaceuticalcomposition of claim 1 wherein each tablet or capsule contains about 20milligrams of zinc.
 3. The pharmaceutical composition of claim 1 whereineach tablet or capsule contains from about 20 milligrams of zinc toabout 150 milligrams of zinc.
 4. A method of treating diabetescomprising administering the composition of claim 1, to a diabeticmammal in a quantity sufficient to reduce blood glucose concentration ina mammal.
 5. A composition for use in the treatment of diabetescomprising an extract of animal prostate tissue and zinc in the form ofa tablet or capsule.
 6. A method for treatment of diabetes of a mammal,comprising administering to the mammal an amount an extract of animalprostate tissue effective for treatment of diabetes.
 7. The method ofclaim 6, wherein said extract of animal prostate tissue iszinc-chelated.
 8. The composition of claim 5, wherein said compositionis crystalline zinc chelated extract of animal prostate tissue.